510(k) · Cleared
ClearedRocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocket Medical Plc · DWM Apparatus, Suction, Patient Care
Cleared on Feb 1, 2013 as substantially equivalent to K112831 (Care Fusion, 2012) after a 126-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971753 (1997). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- 3 generations backK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- 2 generations backK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- 1 generation backK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- This deviceK123033 Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc…Rocket Medical Plc · 2013
- Descendant · cites it directly · 0 of its ownK210509 Rocket Platinum Cured CathterRocket Medical Plc · 2021
- Descendant · cites it directly · 0 of its ownK163321 Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| −3 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| −2 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| −1 | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| 0 (this device) | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing… | Rocket Medical Plc | 2013 | — |
| +1 | K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021 | — |
| +1 | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWM device
- #1 K212696 Aspira Pleural Drainage Systemscore 5.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112831 | Pleurx Pleural Catheter SystemsSummary page 5…acteristics, safety, and performance characteristics to the following legally marketed predicate device: 10.1.1 PleurX Pleural Catheter System (K112831), manufactured by CareFusion… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K210509 (Rocket Medical Plc, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112831.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DWM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWM
Too few DWM 510(k)s in any year since 2007 to give a median.
Recalls per year · DWM
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWM
74in 2025
MAUDE reports naming product code DWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 23 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 78 |
| 2014 | 0 | — | 2 | 94 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 0 | 49 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 0 | — | 0 | 51 |
| 2019 | 1 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 143 |
| 2022 | 0 | — | 0 | 62 |
| 2023 | 1 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines. The…
Read the full statement (120 words)
The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.
The devices are Indicated for
1. The palliation of dyspnea due to pleural effusion
2. Providing pleurodesis (resolution of the pleural effusion).
The Rocket IPC Bottle Sets are Indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026